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- Klinische proef NCT00217529
Erlotinib, Docetaxel, and Carboplatin in Treating Patients With Newly Diagnosed Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
A Phase I-II Study of OSI-774 (Tarceva, Erlotinib) With Docetaxel/Carboplatin Followed by Maintenance Therapy With Tarceva as Treatment for Newly Diagnosed Stage III/IV Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib together with docetaxel and carboplatin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with docetaxel and carboplatin and to see how well they work in treating patients with newly diagnosed stage III or stage IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of erlotinib when administered in combination with docetaxel and carboplatin as front-line therapy in patients with newly diagnosed stage III or IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer.
Secondary
- Determine the toxicity of maintenance therapy with erlotinib when administered after front-line therapy in these patients.
- Determine the proportion of patients who are able to receive the full schedule of treatment courses.
- Determine the objective response rate in patients with measurable or evaluable disease treated with this regimen.
- Determine the progression-free and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of erlotinib.
- Front-line therapy: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1, pegfilgrastim subcutaneously on day 2, and oral erlotinib once daily on days 3-16. Treatment repeats every 21 days for up to 6 courses.
Cohorts of 5 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose-limiting toxicity.
- Maintenance therapy: Beginning 3-4 weeks after the completion of front-line therapy, patients with stable or responding disease receive oral erlotinib once daily for up to 12 months.
After completion of study treatment, patients are followed every 6 months for 1 year and then periodically thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Studietype
Fase
- Fase 2
- Fase 1
Contacten en locaties
Studie Locaties
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Washington
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Seattle, Washington, Verenigde Staten, 98195
- University of Washington School of Medicine
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Seattle, Washington, Verenigde Staten, 98104
- Pacific Gynecology Specialists
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Seattle, Washington, Verenigde Staten, 98109-1024
- Fred Hutchinson Cancer Research Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer
- Stage III or IV disease
The following histologic epithelial cell types are allowed:
- Serous adenocarcinoma
- Mucinous adenocarcinoma
- Clear cell adenocarcinoma
- Endometrioid adenocarcinoma
- Mixed epithelial carcinoma
- Undifferentiated carcinoma
- Transitional cell carcinoma
- Malignant Brenner tumor
- Adenocarcinoma not otherwise specified
- Must have undergone appropriate surgery for ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer within the past 6 weeks
- No borderline ovarian tumor of low malignant potential
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin normal
Meets 1 of the following criteria:
- Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST or ALT normal
- No hepatic disease that would preclude study participation
Renal
- Creatinine ≤ 2.0 mg/dL
- Creatinine clearance > 50 mL/min
- No renal disease that would preclude study participation
Cardiovascular
- LVEF ≥ lower limit of normal*
- No poorly controlled arrhythmia
- No unstable coronary artery disease
- No myocardial infarction within the past year NOTE: *LVEF evaluation performed only on patients requiring it
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
- No peripheral neuropathy ≥ grade 2
- No other nonmalignant systemic disease that would preclude study participation
- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- No medical, social, or psychosocial factor that would preclude study participation
- No psychiatric or addictive disorder that would preclude giving informed consent
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior immunotherapy for this malignancy
Chemotherapy
- No prior chemotherapy for this malignancy
Endocrine therapy
- No prior hormonal therapy for this malignancy
Radiotherapy
- No prior radiotherapy for this malignancy
Surgery
- See Disease Characteristics
No planned interval cytoreductive surgery
- Second-look surgery allowed
Other
- More than 1 year since prior experimental or investigational therapy
- No concurrent therapeutic anticoagulation with warfarin
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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Maximum tolerated dose of erlotinib
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Secundaire uitkomstmaten
Uitkomstmaat |
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|
Responspercentage
|
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Progressievrije overleving
|
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Algemeen overleven
|
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Toxicity of maintenance therapy
|
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Proportion of patients who receive the full schedule of treatment courses
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Dan Veljovich, MD, Pacific Gynecology Specialists
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
- stadium III eierstokepitheelkanker
- stadium IV eierstokepitheelkanker
- eileiderkanker
- ovarium sereus cystadenocarcinoom
- ovarium ongedifferentieerd adenocarcinoom
- ovarium clear cell cystadenocarcinoom
- ovarium endometrioïde adenocarcinoom
- ovarium slijmvlies cystadenocarcinoom
- kanker van de buikholte
- ovarium gemengd epitheelcarcinoom
- Brenner-tumor
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Urogenitale neoplasmata
- Neoplasmata per site
- Carcinoom
- Neoplasmata, glandulair en epitheel
- Genitale neoplasmata, vrouwelijk
- Endocriene systeemziekten
- Ovariële ziekten
- Adnexale ziekten
- Gonadale aandoeningen
- Endocriene klierneoplasmata
- Ziekten van de eileiders
- Ovariumneoplasmata
- Eileiderneoplasmata
- Carcinoom, ovariumepitheel
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Proteïnekinaseremmers
- Docetaxel
- Carboplatine
- Erlotinibhydrochloride
Andere studie-ID-nummers
- PSOC 2001
- PSOC-2001
- AVENTIS-PSOC-2001
- PSOC-IRB-5689
- CDR0000441312 (Register-ID: PDQ)
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